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Completed

NCT Number: NCT04805229

A Difference-In-Differences Analysis of New Persistent Opioid Use After Surgery

The Michigan Opioid Prescribing and Engagement Network (M-OPEN) was established in 2016 with the goal of reducing excessive opioid prescribing after surgery using evidence-based prescribing guidelines. Beginning in July 2016, M-OPEN began a statewide quality improvement campaign to educate providers and share prescribing best practices. This retrospective study examines the effect of these efforts on new persistent opioid use after surgery compared to other states where no such program existed using a difference-in-differences approach.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

In the United States, surgical care has become a gateway for chronic opioid dependence and its associated morbidity. Between 5-10% of patients who receive opioids for postoperative pain control go on to develop long-term opioid use. This translates to more than 2 million previously opioid-naïve individuals developing chronic opioid use after surgery each year. Persistent opioid use after surgery is associated with increased readmissions, healthcare utilization, and healthcare expenditures. Critically, long-term opioid use increases the risk of overdose and death in patients who, prior to their surgery, had no exposure to opioids.

Growing recognition of this problem has led to numerous efforts aimed at reducing opioid-associated morbidity after surgery. These include legislative limits on opioid prescribing for acute pain, procedure-specific prescribing guidelines based on patient-reported opioid use, and opioid-sparing pain management pathways. In Michigan specifically, the Michigan Opioid Prescribing and Engagement Network (M-OPEN) led a statewide quality improvement effort beginning in 2016 that focused on provider education using evidence-based opioid prescribing guidelines. Previously, these guidelines have been shown to significantly reduce excessive postoperative opioid prescribing across the state, however it is currently unknown whether these efforts have had any effect on the actual incidence of persistent opioid use after surgery.

Therefore, the current study will evaluate the incidence of new persistent opioid use before and after the establishment of M-OPEN in Michigan. Beginning in 2016, a statewide quality improvement initiative was undertaken in Michigan to improve postoperative opioid prescribing. In order to accomplish this goal, this study will use a difference-in-differences approach to compare new persistent opioid use in Michigan before and after 2016 to other states where no such quality improvement effort existed.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients (18 years and older)
  • Patients undergoing one of the following procedures: laparoscopic cholecystectomy, laparoscopic appendectomy, minor hernia repair (including laparoscopic or open inguinal, femoral, umbilical, and epigastric hernia repair), open and laparoscopic ventral/incisional hernia repair, laparoscopic colectomy, open colectomy, vaginal hysterectomy, laparoscopic hysterectomy, and open abdominal hysterectomy
  • Patients who underwent surgery between January 1, 2013 and December 31, 2019

Exclusion criteria

  • Patients who are not opioid-naive at the time of surgery, defined as filling 1 or more opioid prescriptions between the 12 months to 31 days prior to surgery
  • Patients without continuous insurance enrollment for at least 12 months before and at least 6 months after the date of surgery
  • Patients still in the hospital on postoperative day 30
  • Patients not discharged home after surgery
  • Patients who underwent another surgery within 6 months of their index operation

Treatment and study plan

Retrospective analysis of opioid use after surgery

Other

Retrospective analysis of opioid use after one of the following surgical procedure categories: laparoscopic cholecystectomy, laparoscopic appendectomy, minor hernia repair (including laparoscopic or open inguinal, femoral, umbilical, and epigastric hernia repair), open and laparoscopic ventral/incisional hernia repair, laparoscopic colectomy, open colectomy, vaginal hysterectomy, laparoscopic hysterectomy, and open abdominal hysterectomy.

Primary outcomes

  1. The change in the incidence of new persistent opioid use before and after July 2016 in Michigan compared to all other states.

    Time frame: Postoperative days 4 to 180

    Among patients who undergo surgery, new persistent opioid use is defined as filling an opioid prescription in post-discharge days 4-90 and filling another opioid prescription in post-discharge days 91-180. This incidence will be measured from 1/1/13-6/30/16 (before M-OPEN established) and from 7/1/16-12/31/19 (after M-OPEN established) and the change before and after this date will be compared between Michigan and all other states (the difference-in-differences). Outcomes will be measured at 1 year, 2 years, and 3 years post-intervention.

Secondary outcomes

  1. The change in the incidence of new persistent opioid use before and after July 2016 in Michigan compared to Indiana and Wisconsin

    Time frame: Postoperative days 4 to 180

    Among patients who undergo surgery, new persistent opioid use is defined as filling an opioid prescription in post-discharge days 4-90 and filling another opioid prescription in post-discharge days 91-180. This incidence will be measured from 1/1/13-6/30/16 (before M-OPEN established) and from 7/1/16-12/31/19 (after M-OPEN established) and the change before and after this date will be compared between Michigan and Indiana/Wisconsin (the difference-in-differences). Outcomes will be measured at 1 year, 2 years, and 3 years post-intervention.

  2. The change in the incidence of new persistent opioid use before and after July 2016 in Michigan compared to 11 other Midwest states (Illinois, Indiana, Iowa, Kansas, Minnesota, Missouri, Nebraska, North Dakota, Ohio, South Dakota, and Wisconsin).

    Time frame: Postoperative days 4 to 180

    Among patients who undergo surgery, new persistent opioid use is defined as filling an opioid prescription in post-discharge days 4-90 and filling another opioid prescription in post-discharge days 91-180. This incidence will be measured from 1/1/13-6/30/16 (before M-OPEN established) and from 7/1/16-12/31/19 (after M-OPEN established) and the change before and after this date will be compared between Michigan and 11 other Midwest states. Outcomes will be measured at 1 year, 2 years, and 3 years post-intervention.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

Using Difference-in-Differences to Evaluate the Effect of a Statewide Quality Improvement Program on New Persistent Opioid Use After Surgery

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Mar 18, 2021
Registry last updated
Mar 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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